Comparison of Analgesic Efficacy of Dexketoprofen and Ibuprofen in Long Bone Fractures: Randomised Controlled Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
The aim of this study was to compare the efficacy of ibuprofen and dexketoprofen, two common analgesic drugs used in pain control in patients with long bone fractures.
详细描述
Long bone fractures are the fractures of long bones (tibia, femur, humerus) in the human body. Such fractures usually occur as a result of trauma and are manifested by symptoms such as pain, swelling, bruising and limitation of movement. Effective control of pain can help the patient relax and facilitate the healing process. Ibuprofen and dexketoprofen, which belong to the class of non-steroidal anti-inflammatory drugs (NSAID), are among the analgesics commonly used in the pain management of all fractures. These drugs are thought to be able to relieve pain, reduce inflammation, and help patients move. However, each patient's individual response and tolerance may differ, so the efficacy and side effects of each drug may vary from patient to patient. This makes it difficult to determine which analgesic is more effective and safe in clinical practice. The fact that it is a subject that has not been done much in the literature has led us to do this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years
- •Patients under 80 years of age
- •Patients who agreed to participate in the study
- •One of the tibia, femur and humerus bones is broken
- •Patients with a VAS score of 50 and above
- •Patients with no other injuries requiring emergency surgery
- •Previously known adverse reactions to the active ingredient of the drugs to be used patients with no history
- •Conscious patients
- •Oriented cooperative patients
排除标准
- •Patients under the age of 18 and over the age of 80
- •Patients who did not agree to participate in the study
- •Patients with vital signs outside the normal limits
- •Patients with a history of adverse reactions to known NSAIDs
- •Those who cannot determine the severity of pain on the VAS
- •Patients with a VAS Score of 50 mm or less
- •Those with other orthopedic injuries pregnant women
- •Those with advanced systemic disease
- •Those with malignancy
- •Those with chronic liver and kidney disease
- •Those who use neuro-psychiatric drugs with sedative and analgesic effects
- •Those with a history of psychological and neurological diseases
- •Patients using analgesics 8 hours before the examination
研究组 & 干预措施
ibuprofen
ibuprofen intravenous 800 mg
干预措施: Ibuprofen 800 mg (Drug)
dexketoprofen
dexketoprofen intravenous 50 mg
干预措施: Dexketoprofen (Drug)
结局指标
主要结局
Visual analog scale
时间窗: 120 minute
The pain is determined using a 100 mm scale. Patients are instructed to mark the level of pain they experience, with 0 mm indicating no pain and 100 mm indicating the presence of maximum pain.
次要结局
未报告次要终点
研究者
Safa Dönmez
Department of Emergency Medicine, M.D. Specialist
Ankara City Hospital Bilkent